Application 064153

Type: ANDA
Sponsor: X GEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACIIM	BACITRACIN	INJECTABLE;INJECTION	50,000 UNITS/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	1997-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	1997-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	1997-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	1997-05-09	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A064153-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A064153-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064153-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064153-001	AP	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
procureFirst Aid Antibio First Aid Antibiotic	BACITRACIN	TWIN MED, LLC	8d19e931-99c4-47b8-b7ec-94c16535166f	2026-08-03	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	AlderMed Inc.	3f0eb4a0-f7bf-45f7-8885-92c65a4bd899	2026-06-08	Warnings	Name fallback generic name: BACITRACIN
Medi-First Bacitracin Zinc	BACITRACIN	Unifirst First Aid Corporation	54609a4f-0fe9-b750-e063-6394a90ae9ce	2026-05-26	Warnings	Name fallback generic name: BACITRACIN
first aid antibiotic	BACITRACIN	HyVee Inc	97c87111-260a-48d0-92cd-e22f55a48c7d	2026-05-12	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Preferred Pharmaceuticals, Inc	5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd9	2026-03-16	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Preferred Pharmaceuticals Inc.	2f115e22-10f5-47fe-85df-f59e4387a373	2026-03-16	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Bryant Ranch Prepack	5b0249c0-c196-4d3c-973f-49bd2d3d4a75	2025-12-01	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Kroger	3f860e7f-487b-d706-e063-6394a90a73ad	2025-11-13	Warnings	Name fallback generic name: BACITRACIN
Zapotol Bacitracin	BACITRACIN	Zapatol Corp.	c8704895-8819-49ac-8baa-5b97be1d00aa	2025-10-22	Warnings	Name fallback generic name: BACITRACIN
MediChoice Bacitracin	BACITRACIN	O&M HALYARD, INC.	78079b94-c6fc-4529-aaad-8186924ecba5	2025-10-09	Warnings	Name fallback generic name: BACITRACIN
MediChoice Triple Antibiotic	BACITRACIN	O&M HALYARD, INC.	8369f399-6f64-4441-be72-1f16c7306c0a	2025-10-09	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Bryant Ranch Prepack	0c081802-429f-468f-9650-293cb7a1ad34	2025-07-29	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	RUGBY LABORATORIES	aa9f414e-d8de-417d-9ccd-027d5a5f5499	2025-06-27	Warnings	Name fallback generic name: BACITRACIN
Drs. Antibiotic Bacitracin	BACITRACIN	OL PHARMA TECH, LLC	c26493c4-0bc1-5fdc-e053-2995a90a81e6	2025-01-09	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	A-S Medication Solutions	64aa660d-2d69-48e8-bd0d-4876815d89ff	2025-01-08	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Water-Jel Technologies	412928a1-3708-4fa8-99c5-aaa2b079cf6e	2025-01-06	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Dynarex Corporation	7f8752c7-6839-261d-e053-2991aa0a0c30	2024-11-20	Warnings	Name fallback generic name: BACITRACIN
BACITRACIN	BACITRACIN	ALLIED TRADE LINK LLC	253e5b98-c64f-3226-e063-6294a90a9352	2024-11-12	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	A-S Medication Solutions	00747e3a-389c-46bc-b6b9-9b3d1d98dbcf	2024-11-06	Warnings	Name fallback generic name: BACITRACIN
BACITRACIN	BACITRACIN	Meijer Distribution Inc	029e7150-1b9a-47c9-90bd-5f8bcd21365c	2024-10-29	Warnings	Name fallback generic name: BACITRACIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
39822-0277	BACiiM	Bacitracin	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0277	BACiiM	Bacitracin	X-GEN Pharmaceuticals, Inc.	ANDA	Current